JRCT ID: jRCT2041220160
Registered date:14/03/2023
AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
Basic Information
Recruitment status | Pending |
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Health condition(s) or Problem(s) studied | Locally advanced unresectable or metastatic melanoma with BRAFV600 mutation and previously untreated |
Date of first enrollment | 10/03/2023 |
Target sample size | 3 |
Countries of recruitment | Canada,Japan,US,Japan,Belgium,Japan,Spain,Japan,France,Japan,Italy,Japan,Netherland,Japan,UK,Japan,Australia,Japan,Brazil,Japan,Czech Republic,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,South Korea,Japan,Portugal,Japan,Russia,Japan,Slovakia,Japan |
Study type | Interventional |
Intervention(s) | Encorafenib: [W00090 GE 2 01 Study] Encorafenib 300 mg (4 x 75 mg) QD, orally. [C4221004 Study] Encorafenib 300 mg or 450 mg QD, orally. Binimetinib: [W00090 GE 2 01 Study] Binimetinib 45 mg (3 x 15 mg) BID, orally. [C4221004 Study] Binimetinib 45 mg BID, orally. Cetuximab: [W00090 GE 2 01 Study] Cetuximab 400 mg/m2 or 500 mg/m2, IV, Q2W. |
Outcome(s)
Primary Outcome | 1. AEs leading to permanent discontinuation of study intervention 2. All SAEs |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade 3 or more or intolerable Grade 2 AEs considered to be related to study treatment. 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 4. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. |
Exclude criteria | 1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study. |
Related Information
Primary Sponsor | Oki Kosuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Kosuke Oki |
Address | Nakanoshima Daibiru 16F, 3-3-23, Nakanoshima, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-6116 |
Telephone | +81-6-4560-6869 |
Kosuke.Oki@ppd.com | |
Affiliation | PPD-SNBL K.K. |
Scientific contact | |
Name | Kosuke Oki |
Address | Nakanoshima Daibiru 16F, 3-3-23, Nakanoshima, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-6116 |
Telephone | +81-6-4560-6869 |
Kosuke.Oki@ppd.com | |
Affiliation | PPD-SNBL K.K. |